Method and System for Transferring Analyte Test Data

ABSTRACT

A system for transferring data includes an analyte test instrument (ATI) adapted to store data, a wirelessly enabled data management device (DMD) for comprehensively analyzing data, and an adaptor removably connected to the ATI for transferring data stored on the ATI to the DMD. The adaptor includes a data communication device capable of removable connection with the ATI, a microprocessor electrically connected to the data communication device, a wireless controller electrically connected to the microprocessor and a wireless transceiver electrically connected to the wireless controller. In use, data transfer is executed between the ATI and the DMD by electrically and mechanically connecting the adaptor to the ATI. Data stored on the ATI is then automatically downloaded into adaptor memory. Upon completion of the download, the user activates an externally accessible input device on the adaptor which, in turn, wirelessly transmits data from the adaptor memory to the DMD.

RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.12/549,296 filed Aug. 27, 2009, now U.S. Pat. No. 8,682,598, which is aContinuation of U.S. patent application Ser. No. 10/407,695 filed Apr.4, 2003, issued as U.S. Pat. No. 7,587,287, entitled “Method and Systemfor Transferring Analyte Test Data”, the disclosures of each of whichare incorporated herein by reference for all purposes.

BACKGROUND OF THE INVENTION

The present invention relates generally to the field of analyte testinstrument systems which can be used to perform electrochemical assayson biological samples. More particularly, the present invention relatesto analyte test instrument systems which include an adaptor fortransferring data stored on an analyte test instrument (e.g., a bloodglucose monitor) to a data management device (e.g., a computer).

For many patients, the concentration of a particular analyte in bloodmust be routinely measured. The results of an analyte concentrationmeasurement may, in turn, necessitate the patient to undertake aparticular course of action in response thereto (e.g., requiring thepatient to partake in a particular drug treatment).

Diabetes is a disease which typically requires a patient to routinelymonitor the concentration of glucose in his/her blood. In particular, apatient suffering from diabetes is often required to measure theconcentration of glucose in his/her blood multiple times each day. Basedupon the results of each blood glucose measurement, the patient mayrequire a particular drug treatment (e.g., an injection of insulin) inorder to regulate that the blood glucose level of the patient remainswithin a specified range. Exceeding the upper limit of said range(hyperglycemia) or dropping beneath the lower limit of said range(hypoglycemia) should be avoided with as much diligence as possible toprevent the patient from experiencing serious medical complicationswhich include, inter alia, retinopathy, nephropathy, and neuropathy.

Analyte test instrument systems are well known and are widely used inthe art to perform routine electrochemical assays on biological samples.A blood glucose monitoring system is one well-known type of analyte testinstrument system which is used to perform routine glucose concentrationtests on blood samples.

One type of blood glucose monitoring system which is well known andwidely used in the art comprises at least one disposable test stripwhich electrochemically reacts in response to the deposition of a bloodsample thereon. The test strip is designed for use with a correspondingblood glucose monitor which calculates the concentration of bloodglucose in the blood sample based upon the electrochemical reactionbetween the test strip and the blood sample. Examples of blood glucosemonitoring systems of the type described above are manufactured and soldby Abbott Laboratories, Medisense Products of Bedford, Mass. under thePRECISION line of blood glucose monitoring systems.

A disposable, blood glucose monitoring test strip typically comprises athin base, or substrate, layer which is generally rectangular in shape.A plurality of electrical contacts, or strips, are deposited alongsubstantially the entire length of the base layer in a spaced apart,parallel relationship. One end of the electrical contacts is positionedwithin the reaction area of the test strip. In the reaction area of thetest strip, an enzyme is deposited which is capable of reacting with theglucose in a blood sample to produce a measurable electrical response.The other end of the electrical contacts is disposed to electricallycontact associated conductors located in the blood glucose monitor, aswill be described further below.

A blood glucose monitor is typically modular and portable inconstruction to facilitate its frequent handling by the patient. A bloodglucose monitor often comprises a multi-function test port which isadapted to receive the test strip in such a manner so that an electricalcommunication path is established therebetween. As such, an electricalreaction created by depositing a blood sample onto the reaction area ofthe test strip travels along at least one of the conductors of the teststrip and into the test port of the blood glucose monitor. Within thehousing of the monitor, the test port is electrically connected to amicroprocessor which controls the basic operations of the monitor. Themicroprocessor, in turn, is electrically connected to a memory devicewhich is capable of storing a multiplicity of blood glucose testresults.

In use, a blood glucose monitor of the type described above can be usedin the following manner to measure the glucose level of a blood sampleand, in turn, store the result of said measurement into memory as testdata. Specifically, a disposable test strip is inserted into the testport of the monitor. With the test strip properly inserted into themonitor, there is established a direct electrical contact between theconductors on the test strip and the conductors contained within thetest port, thereby establishing an electrical communication path betweenthe test strip and the monitor through which electrical signals cantravel. Having properly disposed the test strip into the test port, themonitor typically displays a “ready” indication on its display.

The user is then required to deposit a blood sample onto the reactionarea of the test strip, the acquisition of the blood sample typicallybeing accomplished by pricking the fingertip of the patient with alancing device. When a sufficient quantity of blood is deposited on thereaction area of the test strip, an electrochemical reaction occursbetween the blood sample and the enzyme present in the reaction areawhich, in turn, produces an electrical current which decaysexponentially over time.

The decaying electrical current created through the chemical reactionbetween the enzyme and the glucose molecules in the blood sample, inturn, travels along the electrically conductive path established betweenthe test strip and the monitor and is measured by the microprocessor ofthe monitor. The microprocessor of the monitor, in turn, correlates thedeclining current to a standard numerical glucose value. The numericalglucose value calculated by the monitor is then shown on the monitordisplay for the patient to observe. In addition, the data associatedwith the particular blood glucose measurement is stored into the memoryfor the monitor.

It should be noted that blood glucose monitors of the type describedabove often include a memory device which is capable of storing a numberof different events, wherein examples of some possible events include,but are not limited to, a blood glucose measurement, a calibrationfunction, and a date/time change for the monitor. In fact, some bloodglucose monitors are capable of storing in memory as many as 400 eventsat a single time.

In order to effectively monitor the blood glucose level patterns of apatient, a clinician and/or physician for a diabetes patient oftendownloads a series of blood glucose monitoring events onto a datamanagement device, such as a computer, which is loaded withcomprehensive data management system (DMS) software (e.g., the PRECISIONLINK data management system software which is manufactured and sold byAbbott Laboratories, MediSense Products of Bedford, Mass.) capable ofretrieving, managing and analyzing the data stored on the monitor. Inparticular, a clinical analyst and/or a physician for a diabetes patientis often interested in tracking the blood glucose levels of a patientover a fixed period of time (e.g., 1 month).

In order to effectively track the blood glucose levels of a patient overa fixed time, a clinical analyst and/or a physician is required toperiodically meet with the patient and download all of the data storedin the blood glucose monitor into the data management device forcomprehensive analysis. Analyzing the test results in this manner, theclinician and/or physician is able to assess how effectively the patientis able to regulate his/her blood glucose level.

Traditionally, the data stored on a blood glucose monitor is downloadedonto a data management device using a hardwire communication link. Ahardwire communication link typically comprises a communication cablewhich, at one end, is provided with a test strip-shaped communicationinterface which can be removably inserted into the strip port of theblood glucose monitor and, at the other end, is provided with aconnector which is adapted to removably connect with the serial port ofa conventional computer.

As can be appreciated, a diabetes patient is somewhat limited in thefrequency in which he/she can visit a clinician and/or physician totrack glucose test results. As a result, diabetes patients areencouraged to frequently download the data stored on the blood glucosemonitor onto his/her own computer for comprehensive analysis. In thismanner, a diabetes patient can monitor his/her test results asfrequently as desired (e.g., daily, weekly, etc.).

However, the process of electrically connecting a blood glucose monitorto a computer using a hardwire communication link has been found by somediabetes patients to be cumbersome, complicated, and time consuming.Overwhelmed by the connection process, some patients download theirblood glucose levels onto a computer for further analysis lessfrequently than is desired, thereby increasing the patient's risk ofexperiencing a serious diabetes related medical complication, which ishighly undesirable.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a method and systemfor wirelessly transferring analyte test data stored on an analyte testinstrument, such as a blood glucose monitor, to a data managementdevice, such as a computer.

It is another object of the present invention to provide a method andsystem for transferring analyte test data stored on an analyte testinstrument to a data management device via an adaptor.

It is yet another object of the present invention to provide a methodand system as described above wherein the adaptor can be removablyconnected to the analyte test instrument.

It is yet still another object of the present invention to provide amethod and system as described above which has a limited number ofparts, which is inexpensive to manufacture and which is easy to use.

Therefore, according to one feature of the present invention, there isprovided a system for transferring data comprising an analyte testinstrument which is adapted to store data, an adaptor removablyconnected to said analyte test instrument, said adaptor being in datacommunication with said analyte test instrument through a first datacommunication channel, and a data management device in datacommunication with said adaptor through a second data communicationchannel, said second communication channel being a wireless datacommunication channel.

According to another feature of the present invention, there is providedan adaptor for transferring data stored on an analyte test instrument toa wirelessly enabled data management device, said analyte testinstrument comprising a data communication device, said adaptorcomprising a data communication device, said data communication devicefor said adaptor being adapted to removably connect with the datacommunication device of said analyte test instrument so as to establisha first data communication channel between said adaptor and said analytetest instrument, a microcontroller in electrical connection with saiddata communication device for said adaptor, a wireless controller inelectrical connection with said microcontroller; and a wirelesstransceiver in electrical connection with said wireless controller, saidwireless transceiver being adapted to wirelessly communicate with saiddata management device through a second data communication channel.

According to another feature of the present invention, there is provideda method for transferring data stored on an analyte test instrument to adata management device via an adaptor, said adaptor being independentfrom said analyte test instrument, said method comprising the steps ofremovably connecting said adaptor to said analyte test instrument so asto establish a first data communication channel between said adaptor andsaid analyte test instrument, transferring data stored on said analytetest instrument to said adaptor through the first data communicationchannel, and transmitting the transferred data from said adaptor to saiddata management device through a second data communication channel, thesecond data communication channel being a wireless data communicationchannel.

Various other features and advantages will appear from the descriptionto follow. In the description, reference is made to the accompanyingdrawings which form a part thereof, and in which is shown by way ofillustration, various embodiments for practicing the invention. Theembodiments will be described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is to be understoodthat other embodiments may be utilized and that structural changes maybe made without departing from the scope of the invention. The followingdetailed description is therefore, not to be taken in a limiting sense,and the scope of the present invention is best defined by the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings wherein like reference numerals represent like parts:

FIG. 1 is a perspective view of a first embodiment of a system fortransferring analyte test data, said system being constructed accordingto the teachings of the present invention, the adaptor being shownconnected to the analyte test instrument, the adaptor being shown inwireless communication with the data management device;

FIG. 2 is a simplified block diagram of the system shown in FIG. 1;

FIG. 3( a) is a front plan view of the analyte test instrument and theadaptor shown in FIG. 1, the adaptor being shown connected to theanalyte test instrument;

FIG. 3( b) is a right side view of the analyte test instrument and theadaptor shown in FIG. 1, the adaptor being shown connected to theanalyte test instrument;

FIG. 3( c) is a rear perspective view of the analyte test instrument andthe adaptor shown in FIG. 1, the adaptor being shown connected to theanalyte test instrument;

FIG. 4 is an enlarged front perspective view, broken away in part, ofthe analyte test instrument shown in FIG. 1;

FIG. 5 is an enlarged front plan view of the display for the analytetest instrument shown in FIG. 1;

FIG. 6( a) is an enlarged, front perspective view of the adaptor shownin FIG. 1;

FIG. 6( b) is an enlarged, rear perspective view of the adaptor shown inFIG. 1;

FIG. 6( c) is an enlarged, front plan view of the adaptor shown in FIG.1;

FIG. 6( d) is an enlarged, right side view, broken away in part, of theadaptor shown in FIG. 1;

FIG. 7 is a flow chart depicting the method in which the system shown inFIG. 1 transfers data from the analyte test instrument to the adaptor;

FIG. 8 is a flow chart depicting the method in which the system shown inFIG. 1 wirelessly transmits data from the adaptor to the data managementdevice;

FIG. 9 is a perspective view of a second embodiment of a system fortransferring analyte test data, said system being constructed accordingto the teachings of the present invention, the adaptor being shownconnected to the analyte test instrument, the adaptor being shown inwireless communication with the data management device; and

FIG. 10 is an enlarged front perspective view of the analyte testinstrument and the adaptor shown in FIG. 9, the adaptor being showndisconnected from the analyte test instrument.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIGS. 1 and 2, there is shown a first embodiment of asystem for transferring data, said system being constructed according tothe teachings of the present invention and identified generally byreference numeral 11.

System 11 comprises an analyte test instrument (ATI) 13, a datamanagement device (DMD) 15, and an adaptor 17. As will be describedfurther in detail below, analyte test data stored in ATI 13 can bewirelessly transmitted to DMD 15 via adaptor 17.

Analyte test instrument 13 represents a monitor which can be used tomeasure the concentration of an analyte in a test sample. As is shownherein, ATI 13 is in the form of a conventional blood glucose monitor(e.g., an electrochemical or photometric blood glucose monitor). Assuch, ATI 13 is capable of measuring glucose concentrations of a bloodsample and, in turn, storing the results of each blood glucosemeasurement as data in memory. As an example, ATI 13 may be of the typedisclosed in U.S. Pat. No. 6,377,894 to Deweese et al, which isincorporated herein by reference.

ATI 13 is a communication enabled device. In this respect, ATI 13 iscapable of serial data transfer with another device (e.g., adaptor 17),as will be described further in detail below.

Referring now to FIGS. 2-4, ATI 13 is a modular, self-contained, andportable unit which comprises a protective housing 19 constructed of adurable and inexpensive material, such as plastic. Housing 19 includes afront casing 21 and a rear casing 23 which are secured together by meansof a snap-fit interconnection. With front casing 21 and rear casing 23affixed together, housing 19 is a substantially enclosed device which isshaped to include an interior cavity 25 into which the electrical andelectronic components of ATI 13 are disposed, as will be describedfurther below.

ATI 13 comprises a data communication device 27 which is disposed withininterior cavity 25 of housing 19 and which is accessible through a slot29 formed into the top of housing 19. Data communication device 27 is acurrent source sensing device which is capable of transmitting andreceiving serial data. In the present embodiment, data communicationdevice 27 is in the form of a conventional multi-purpose test port whichincludes a slot shaped to fittingly receive and electrically connectwith, inter alia, a test strip, a calibration strip, or the interfaceconnector of a hardwire communication link. Data communication device 27comprises six metal contact strips, which are identified as contactstrips Cont1 through Cont6 in FIG. 2.

It should be noted that data communication device 27 is not limited to aconventional multi-purpose test port. Rather, it is to be understoodthat data communication device 27 could be in the form of anyconventional communication device which is capable of transmitting andreceiving serial data without departing from the spirit of the presentinvention. As one example, data communication device 27 couldalternatively be in the form of a wireless transceiver without departingfrom the spirit of the present invention. As another example, datacommunication device 27 could alternatively be in the form of a phonejack receptacle without departing from the spirit of the presentinvention, which will be described further in detail below.

ATI 13 also comprises a user input device 31 which is disposed withininterior cavity 25 and which at least partially projects through anopening formed in front casing 21 of housing 19. User input device 31 isshown herein as being in the form of a button capable of being manuallydepressed. In use, input device 31 is for the manual regulation of aswitch which, in turn, controls operative functions for ATI 13. Inparticular, input device 31 enables the user to regulate the power stateof ATI 13, to recall information stored in memory, to respond tomessages provided in the display, to provide access to menus generatedby software contained within ATI 13, and to set some of theconfiguration control parameters.

ATI 13 further comprises a display 33 which is disposed within interiorcavity 25 and which is viewable through a transparent window formed infront casing 21 of housing 19. Display 33 is shown herein as being inthe form of a screen designed to provide the user with information in avisual form. As can be seen most clearly in FIG. 5, display 33 is in theform of a liquid crystal display (LCD) which is used to display, interalia, test results, user messages, and recalled information which isstored in the memory of ATI 13. Display 33 includes a numerical display35 which is capable of generating three, seven-segment digital numbers.As can be appreciated, display 35 provides the user with a means forvisually indicating the numerical value associated with a particulartest result, display 35 including a pair of decimal point indicators toallow for a wider range of possible output values. Display 33 alsocomprises a plurality of icons 37 which indicate the units ofmeasurement of a test result (e.g., mg/dL or mmol/l) and a low batterycondition. Display 33 further comprises a dot-matrix message line 39which can be used to provide information to the user, message line 39being capable of generating up to 10 numerals or up to 9 characters atthe same time. The information displayed by message line 39 can include,among other things, time and data information, user prompts (e.g.,“apply blood”), error messages (e.g., “expired strip”), andconfiguration control settings (e.g., setting time or selecting aoperating language).

It should be noted that the information shown on display 33 iscontrolled by display driver software for ATI 13. The display driversoftware provides display 33 with the ability to scroll a long message,flash a message or a portion of a message, or display alternatingmessages. In addition, the display driver software can provide ATI 13with the ability to flash icons 37. Furthermore, as ATI 13 is poweringup, the display driver software can support a visual check of display 33wherein the icons and pixels for display 33 are turned on for a briefperiod to enable the user to confirm the entire display 33 isfunctioning properly.

ATI 13 preferably derives power from a power source (not shown) disposedwithin interior cavity 25. The power source may be in the form of one ormore replaceable AA-type batteries which are removably mounted into anassociated battery compartment in interior cavity 25 and which areaccessible through a removable cover formed into rear casing 23 ofhousing 19. However, it is to be understood that any source of powercapable of providing a suitable direct (DC) voltage can be used toprovide power to ATI 13.

As seen most clearly in FIG. 2, user input 31 and display 33 areconnected to a processing circuit 41 which, in turn, is connected to amicroprocessor 43, memory 45, and instrument software 47. In addition,data communication device 27 is connected to processing circuit 41through a test strip circuit 49.

Processing circuit 41 is an application specific integrated circuit(ASIC) which enables a test strip to be inserted into direct electricalconnection with data communication device 27 to communicate withmicroprocessor 43. For example, processing circuit 41 enablesmicroprocessor 43 to send signals to data communication device 27 todetermine the identity of a strip which is disposed into electricalconnection therewith (i.e., to determine whether the strip is acalibration strip, a test strip, or the strip-like interface connectorfor a communication link). Microprocessor 43 may determine the identityof a strip disposed into electrical connection with data communicationdevice 27 by measuring the impedance of said strip or by detecting thelocation of the electrical contacts on said strip.

Microprocessor 43 is an application specific integrated circuit (ASIC)that functions as the central processing unit for ATI 13. As such,microprocessor 43 performs the principal calculation and data managementtasks for ATI 13.

Memory 45 is connected to microprocessor 43 and serves to retain dataprocessed by microprocessor 43, said data being available for subsequentretrieval. Types of information that may be stored in memory 45 includemeasurement delay times, sample incubation times, number of measurementsto be taken during an assay, thresholds against which voltage levels canbe compared, values of excitation voltage levels applied to a test stripduring assay, analyte value conversion factors, failsafe assay thresholdvalues, and configurations of circuitry of analyte test instrument 13.It should be noted that memory 45 has the capacity to store amultiplicity of assay results. Specifically, each assay result istypically stored into memory 45 as a data bundle referred to herein as“an event”. As can be appreciated, memory 45 is preferably of the typewhich can store in excess of 400 events.

Instrument software 47 is provided for microprocessor 43, software 47functioning in response to information received at data communicationdevice 27 from a calibration strip. Specifically, instrument software 47uses the information received from a calibration strip to control theoperation of the ATI 13. Instrument software 47 also controls operationsof the ATI 13 that are independent of information introduced orgenerated at data communications device 27. For example, instrumentsoftware 47 enables the user to recall assay results and assayinformation, can provide various warning, error, and prompting messages,can permit setting of date and time, can control transmission of data toexternal devices, can monitor power level or battery level or both, andcan provide indications to the user if power drops below a specifiedlevel.

A test strip circuit 49 connects data communication device 27 toprocessing circuit 41. In operation, test strip circuit 49 enables datato pass between data communication device 27 and processing circuit 41.

A pair of device circuits 51 are also connected to processing circuit41. Device circuits 51 can comprise analog, digital, or mixed-signalcircuits, application-specific integrated circuits (ASICs), and passiveand active electrical components. Device circuits 51 can perform variouselectrical functions required by ATI 13. Specifically, device circuits51 carry instructions from microprocessor 43 to various functionalcomponents of ATI 13 so that these components can perform their intendedfunctions. As one example, device circuits 51 may serve to drive theclock functions for microprocessor 43.

In use, ATI 13 can be used in the following manner to measure and storeanalyte test data. Specifically, an analyte test strip is inserted intodata communication device 27 so that the metal contacts on the teststrip are in direct metal-to-metal contact with the contacts CONT1through CONT6 of data communication device 27, thereby establishing acommunication channel between the test strip and ATI 13. Having insertedthe test strip into data communication device 27, instrument software 47identifies the item inserted into data communication device 27 as ananalyte test strip. At this time, microprocessor 43 executes softwarewhich generates a message on display 33 that notifies the user todeposit a sample onto the test strip. When a sample is deposited ontothe reaction area of the test strip, the sample reacts with enzymes inthe reaction area which, in turn, produces an electrical response in theform of a decaying electrical current. Test strip circuit 49 convertsthe decaying current from an analog signal to a digital signal and thenpasses the converted signal to processing circuit 41. The convertedsignal is then processed by microprocessor 43 to determine the analytetest value that corresponds to the signal. Microprocessor 43 then storesthe analyte test data as an event in memory 45 and simultaneouslyregisters the analyte test value on display 33 for the patient to read.

The aforementioned analyte testing process can be repeated as desired.As noted briefly above, each test performed is preferably stored intomemory 45 as an event, memory 45 being capable of storing a largequantity of events which can be subsequently retrieved and analyzed by apersonal computer using sophisticated data management software.

Although ATI 13 is represented herein as being in the form of acommunication enabled, blood glucose monitor, it is to be understoodthat ATI 13 represents any conventional communication enabled devicewhich can be used to measure the concentration of an analyte in asample. As an example, ATI 13 may represent any of the PRECISION line ofblood glucose monitors which are manufactured and sold by AbbottLaboratories, MediSense Products of Bedford, Mass.

Data management device (DMD) 15 is represented herein as being in theform of a wirelessly enabled, laptop computer. As such, DMD 15 iscapable of serial data transfer with another device (e.g., adaptor 17)through a wireless communication channel. Preferably, DMD 15 is providedwith comprehensive data analysis software (e.g., the PRECISION LINKsoftware manufactured and sold by Abbott Laboratories, MediSenseProducts of Bedford, Mass.) which allows for analyte test data stored onan analyte testing device (e.g., ATI 13) to be downloaded, managed, andanalyzed (e.g., charted) by DMD 15, thereby providing the patient withsophisticated analyte test data monitoring and tracking capabilities,which is highly desirable.

Although DMD 15 is represented herein as being in the form of awirelessly enabled, laptop computer, it is to be understood that DMD 15is not limited to a wirelessly enabled laptop computer. Rather, DMD 15could be in the form of other types of conventional, wirelessly enableddata management devices (e.g., desktop computer, personal data assistant(PDA), printer, etc.) without departing from the spirit of the presentinvention.

Adaptor 17 is a modular, self-contained and portable unit which can beremovably connected to ATI 13, as seen most clearly in FIGS. 3( a)-(c).As will be described further in detail below, adaptor 17 is adapted tocommunicate with ATI 13 by means of a first communication channel 53 andwirelessly communicate with DMD 15 by means of a second communicationchannel 55. In this capacity, adaptor 17 can be used to retrieve data(e.g., analyte test data) stored in memory 45 via first communicationchannel 53 and, in turn, wirelessly transmit said data to DMD 15 viasecond communication channel 55.

As seen most clearly in FIGS. 2 and 6( a)-(d), adaptor 17 comprises aprotective housing 57 constructed of a durable and inexpensive material,such as plastic. Housing 57 is a substantially enclosed device which isshaped to define an interior cavity 59 which is shaped to substantiallyreceive the electrical and electronic components of adaptor 17, as willbe described further below.

Adaptor 17 comprises a data communication device 61 disposed withininterior cavity 59 and which partially and fittingly protrudes outthrough a narrow slot formed in the bottom of housing 57. Datacommunication device 61 is a communication device which is capable ofelectrically connecting with data connection device 27 of ATI 13, so asto establish communication channel 53 between ATI 13 and adaptor 17through which data can be transmitted and received.

In the present embodiment, the portion of data communication device 61which extends out from housing 57 is in the form of a rectangular strip63 having the same approximate width and thickness as a test strip usedin conjunction with data communication device 27. Six metal contactstrips, which are identified as contact strips Cont1 through Cont6 inFIGS. 2 and 6( a)-(c), are deposited along substantially the entirelength of strip 63 in a spaced apart, parallel relationship. As such,when strip 63 of data communication device 61 is inserted into the testport configuration of data communication device 27, each of the contactstrips, or leads, on data communication device 61 is disposed in directconductive contact with an associated contact strip within the testport. In this manner, with data communication device 61 properlyinserted into the test port slot for data communication device 27,communication channel 53 is established between ATI 13 and adaptor 17through which serial data is capable of being transferred.

It should be noted that the particular construction of datacommunication device 61 enables adaptor 17 to be removably connected toATI 13. As a result, adaptor 17 can be manufactured and storedseparately from ATI 13, adaptor 17 being connected to ATI 13 to formcommunication channel 53 only when the user desires to send data fromATI 13 to DMD 15.

As can be appreciated, the ability to removably connect adaptor 17 toATI 13 provides the user with a number of significant advantages. As afirst advantage, when the user only desires to store data onto ATI 13and is not interested in wirelessly transmitting said data to DMD 15,adaptor 17 can be separated from ATI 13, thereby reducing the overallsize and weight of the unit, which is highly desirable. As a secondadvantage, the particular construction of data communication device 61enables adaptor 17 to be used in conjunction with many types ofpre-existing types of analyte test instruments. As a result, a patientwho owns a pre-existing ATI which is compatible with adaptor 17 canwirelessly transmit data stored on said pre-existing ATI to a datamanagement device, such as a computer, simply by purchasing adaptor 17,which is highly desirable.

It should be noted that data communication device 61 is not limited tothe test strip-type configuration shown herein. Rather, it is to beunderstood that data communication device 61 could be in the form ofalternative types of conventional communication devices which arecapable of transmitting and receiving serial data without departing fromthe spirit of the present invention. Specifically, data communicationdevice 27 and data communication device 61 represent any compatiblemeans for establishing a communication channel (e.g., wireless,hardwire) therebetween. As will be described further in detail below,data communication device 61 may be in the form of a male, phone jackand data communication device 27 may be in the form of a female, phonejack receptacle without departing from the spirit of the presentinvention.

Data communication device 61 is electrically connected to amicrocontroller 65 via universal asynchronous receiver transmitter(UART) communication bus 67, microcontroller 65 being disposed withininterior cavity 59 of housing 57. Microcontroller 65 is an applicationspecific integrated circuit (ASIC) which functions as the centralprocessing unit for adaptor 17. As such, microcontroller 65 isresponsible for, inter alia, the processing and managing of data whichis retrieved from ATI 13 and wirelessly transmitted to DMD 15, as willbe described further in detail below.

For purposes of the present specification and claims, the termmicrocontroller shall mean microcontroller or microprocessor unlessotherwise specified.

Memory 69 is disposed within interior cavity 59 of housing 57 and iselectrically connected to microcontroller 65 through a communication bus71. As will be described further below, memory 69 serves two principalfunctions. As a first function, memory 69 stores the application codesoftware for adaptor 17. As a second function, memory 69 temporarilystores (i.e., buffers) the data retrieved from ATI 13 prior to itstransmission to DMD 15. It should be noted that memory 69 preferablyincludes two separate memory devices, one of said memory devices beingresponsible for storing the application code software for adaptor 17 andthe other of said memory device being responsible for temporarilystoring the data retrieved from ATI 13 prior to its transmission to DMD15.

A wireless controller 73 is disposed within interior cavity 59 ofhousing 57 and is electrically connected to microcontroller 65 viauniversal asynchronous receiver transmitter (UART) communication bus 75.As will be described further in detail below, in response to commandssent by microcontroller 65, wireless controller 73 serves to regulatethe operation of a wireless transceiver 75.

For purposes of the present specification and claims, wirelesscontroller 73 represents both a component which is physically separatefrom microcontroller 65 as well as a component which is physicallyincorporated into microcontroller 65 to form an integrated device unlessotherwise specified.

Wireless transceiver 75 is disposed within interior cavity 59 of housing57 and is electrically is connected to wireless controller 73 via atransmitter line TxD and a receiver line RxD, electrical signals passingfrom controller 73 to transceiver 75 traveling via transmitter line TxDand electrical signals passing from transceiver 75 to controller 73traveling via receiver line RxD. As will be described further in detailbelow, wireless transceiver 75 serves to transmit electrical signals toDMD 15 and receive electrical signals from DMD 15. Preferably, wirelesstransceiver 75 is disposed within interior cavity 59 in close proximityto a window 77 formed into the top of housing 57 through which signalsare capable of traveling.

It should be noted that wireless transceiver 75 represents anyconventional transceiver which is capable of two-way communication witha communication enabled device. As a result, wireless communicationchannel 55 represents any conventional two-way wireless communicationchannel (e.g., infrared (IR), such as infrared data (IrDA), or radiofrequency (RF), such as Bluetooth®, 802.11, Zigbee®).

A power source 79 is disposed within interior cavity 59 of housing 57and is electrically connected to microcontroller 65, memory 69, wirelesscontroller 73 and wireless transceiver 75. Power source 79 is preferablyin the form of a replaceable 3 volt, coin cell lithium battery which isaccessible through a door 81 which is slidably mounted onto housing 57.However, it is to be understood that power source 79 is not limited to a3 volt, coin cell lithium battery. Rather, it is to be understood thatpower source 79 could be in the form of additional types of conventionalpower sources (e.g., a solar battery cell) without departing from thespirit of the present invention. In addition, it is to be understoodthat power source 79 could be eliminated entirely from adaptor 17without departing from the spirit of the present invention.Specifically, if power source 79 were to be removed from adaptor 17,power could alternatively be supplied to adaptor 17 from the powersource of ATI 13.

A user input device 83 is disposed within interior cavity 59 and issized and shaped to fittingly project through a corresponding openingformed in the front of housing 57. User input device 83 is preferably inthe form of a circular button which can be manually depressed so as toselectively close a switch which is electrically connected tomicrocontroller 65. As will be described further below, input device 83serves as a finger actuable means for triggering the execution of thedata transfer from adaptor 17 to DMD 15.

An indicator 85 is disposed within interior cavity 59 and is sized andshaped to fittingly project through a corresponding opening formed inthe front of housing 57. Indicator 85 is preferably in the form of agreen light emitting diode (LED) which is electrically connected tomicrocontroller 65. As will be described further in detail below,indicator 85 serves as a means for providing the user with a visualindication of the operating state of indicator 85 (e.g., whetherindicator 85 is transferring data to DMD 15).

As noted above, system 11 is capable of transferring data stored inmemory 45 of ATI 13 to DMD 15 via adaptor 17. As will be describedfurther below, system 11 transfers data stored on ATI 13 to DMD 15 viaadaptor 17 by means of a two-step process. In the first step of the twostep process, data stored in memory 45 of ATI 13 is transferred intobuffer memory 69 of adaptor 17. In the second step of the two stepprocess, data transferred into buffer memory 69 of adaptor 17 is, inturn, wirelessly transmitted to DMD 15. Each of the two aforementionedsteps will be discussed further in detail below.

FIG. 7 is a flow chart illustrating the method in which system 11transfers data from ATI 13 to adaptor 17, said method being representedgenerally by reference numeral 101. Method 101 commences once datacommunication channel 53 is established between ATI 13 and adaptor 17,said step being represented by reference numeral 103. It should be notedthat, for system 11, data communication channel 53 is establishedbetween ATI 13 and adaptor 17 by inserting strip 63 of datacommunication device 61 into the corresponding test port slot of datacommunication device 27, wherein the electrical conductors on datacommunication device 61 are disposed in direct electrical contactagainst the electrical conductors within data communication device 27.

Having established data communication channel 53 between ATI 13 andadaptor 17 in step 103, adaptor microcontroller 65 becomes active, or“wakes up”, in anticipation of the transfer of data between ATI 13 andadaptor 17, said step being represented by reference numeral 105.Specifically, once data communication channel 53 has been establishedbetween ATI 13 and adaptor 17, the protocol for ATI 13 is to send out asignal to determine the type of device (e.g., adaptor, analyte teststrip, calibration test strip) connected to data communication device27. It is this signal sent by ATI 13 to determine the type of deviceconnected to data communication device 27 which, in turn, serves toactivate adaptor microcontroller 65. Once adaptor microcontroller 65becomes active, adaptor microcontroller 65 then sends a signal toactivate, or “wake up”, microprocessor 43 for ATI 13 in anticipation ofdata transfer between ATI 13 and adaptor 17, said step being representedby reference numeral 107.

With adaptor microcontroller 65 and ATI microprocessor 43 having beenactivated in steps 105 and 107, adaptor microcontroller 65 receives afirst bundle of data stored in memory 45 of ATI 13, said step beingrepresented by reference numeral 109. It should be noted that adaptormicrocontroller 65 is programmed to understand the protocol of ATI 13(e.g., ASTM 1381 protocol) and, as a result, can recognize theparticular bundles, or packets, of data stored in memory 45 of ATI 13.Having received the first bundle of data in step 109, adaptormicrocontroller 65 processes (i.e., reformats and sorts) the firstbundle of data in order to render said bundle in compliance with thedata receiving protocol for DMD 15, said step being represented byreference numeral 111. In step 113, the first bundle of processed datain microcontroller 65 is then buffered into memory 69.

Having completed the transfer of the first bundle of data from memory 45of ATI 13 to buffer memory 69 of adaptor 17, microcontroller 65 thensends a signal to microprocessor 43 to determine whether additionalbundles of data remain in memory 45 for ATI 13 that need to be retrievedby adaptor 17, said step being represented by reference numeral 115. Ifthere are no additional bundles of data located in memory 45 of ATI 13,the data transfer process between ATI 13 and adaptor 17 ends, asrepresented by reference numeral 117.

However, if additional bundles of data are located in memory 45 of ATI13, adaptor microcontroller 65 receives the next sequential bundle ofdata stored in memory 45 of ATI 13, said step being represented byreference numeral 119. Having received the next sequential bundle ofdata in step 119, adaptor microcontroller 65 processes said bundle ofdata in step 121. In step 123, said bundle of processed data inmicrocontroller 65 is then buffered into memory 69.

Having completed the transfer of the next sequential bundle of data fromATI 13 to adaptor 17, microcontroller 65 then sends an additional signalto microprocessor 43 to determine whether more bundles of data remain inmemory 45 of ATI 13 that need to be retrieved by adaptor 17, said stepbeing represented by reference numeral 125. If there are no additionalbundles of data located in memory 45, method 101 proceeds to step 117.However, if additional bundles of data are located in memory 45 of ATI13, method 101 returns to step 119. As such, method 101 continues untilall the bundles of data in memory 45 for ATI 13 are properly transferredinto memory 69 for adaptor 17.

Having completed the first step of the two-step process for transferringdata from ATI 13 to DMD 15 via adaptor 17, system 11 is now prepared toexecute the second step of the two-step process for transferring datafrom ATI 13 to DMD 15 via adaptor 17. More specifically, system 11 isnow prepared to wirelessly transmit the data buffered into memory 69 ofadaptor 17 to wirelessly enabled DMD 15. FIG. 8 is a flow chartillustrating the method by which system 11 transfers data from memory 69of adaptor 17 to DMD 15, said method being represented generally byreference numeral 201.

Method 201 commences once user input device 83 on adaptor 17 isactivated (i.e., depressed), said step being represented by referencenumeral 203. The activation of user input device 83 in step 203, causesadaptor microcontroller 65 to become active, or “wake up”, inanticipation of data transfer between adaptor 17 and DMD 15, said stepbeing represented by reference numeral 205.

Once activated, adaptor microcontroller 65 instructs wireless controller73 to have wireless transceiver 75 send out a signal through window 77in order to establish a data communication channel 55 between adaptor 17and DMD 15, said step being represented by reference numeral 207. Itshould be noted that during step 207, adaptor microcontroller 65simultaneously instructs indicator 85 to provide a signal (e.g., aflashing green light) to notify the user of the attempt by adaptor 17 toestablish a data communication channel 55 with DMD 15. If compatible,adaptor 17 and DMD 15 will be able to establish data communicationchannel 55, said step being represented by reference numeral 209. Itshould be noted that, upon establishing data communication channel 55between adaptor 17 and DMD 15, adaptor microcontroller 65 simultaneouslyinstructs indicator 85 to provide a signal (e.g., a solid, non-flashinggreen light) to notify the user of the established data communicationchannel.

With data communication channel 55 having been established betweenadaptor 17 and DMD 15, adaptor microcontroller 65 retrieves a firstbundle of data from adaptor memory 69 and, in turn, sends said firstbundle of data to wireless controller 73, as represented by referencenumeral 211. It should be noted that the size of the first data bundleretrieved from adaptor memory 69 is dependent upon the transfer protocolestablished between adaptor 17 and DMD 15. In step 213, wirelesscontroller 73 converts the first bundle of received data into a formatsuitable for wireless transmission. The converted first bundle of datais then sent from wireless controller 73 to wireless transceiver 75through transmission line TxD, said step being represented by referencenumeral 215. In step 217, the converted first bundle of data iswirelessly transmitted from wireless transceiver 75 to DMD 15.

Having completed the transfer of the first bundle of data from adaptor17 to DMD 15, microcontroller 65 then sends out a signal to determinewhether additional data bundles remain in adaptor memory 69, said stepbeing represented by reference numeral 219. If there are no additionalbundles of data located in memory 69, the data transfer process betweenadaptor 17 and DMD 15 terminates, as represented by reference numeral221. It should be noted that once method 201 reaches step 221, adaptormicrocontroller 65 simultaneously turns off indicator 85 to notify theuser that the transfer of data between adaptor 17 and DMD 15 hascompleted.

However, if additional bundles of data are located in memory 69, adaptormicrocontroller 65 retrieves the next sequential bundle of data fromadaptor memory 69 and, in turn, forwards said bundle to wirelesscontroller 73, as represented by reference numeral 223. In step 225,wireless controller 73 converts the next sequential bundle of receiveddata into a format suitable for wireless transmission. The convertedbundle of data is then sent from wireless controller 73 to wirelesstransceiver 75 through transmission line TxD, said step beingrepresented by reference numeral 227. In step 229, the converted bundleof data is wirelessly transmitted from wireless transceiver 75 towireless enabled DMD 15.

Having completed the transfer of the next sequential bundle of data fromadaptor 17 to DMD 15, microcontroller 65 then sends an additional signalto determine whether more bundles of data remain in memory 69 foradaptor 17, said step being represented by reference numeral 231. Ifthere are no additional bundles located in adaptor memory 69, method 201proceeds to step 221. However, if additional bundles of data are locatedin adaptor memory 69, method 201 returns to step 223. As such, method201 continues until all of the bundles of data stored in adaptor memory69 are wirelessly transmitted to DMD 15.

As noted above, data communication device 61 of adaptor 17 is preferablyin the form of a strip-type connective interface which includes multiplemetal contacts and communication device 27 is preferably in the form ofa slotted, multi-purpose test port which includes multiple metalcontacts. Preferably, the strip-type connective interface of device 61is sized and shaped to be fittingly inserted into the slot of themulti-purpose test port of device 27 so that the metal contacts ofdevice 61 are disposed in direct electrical contact with the metalcontacts within device 27. In this manner, data communication channel 53is established between ATI 13 and adaptor 17.

However, it is to be understood that system 11 is not limited to theparticular type of electrical interconnection between ATI 13 and adaptor17 as described above. In particular, system 11 is not limited to datacommunication device 61 being in the form of a strip-type connectiveinterface with multiple metal contacts and data communication device 27being in the form of a multi-purpose test port with multiple metalcontacts. Rather, it is to be understood that data communication devices27 and 61 are meant to represent any complementary pair of connectorswhich can be removably interconnected so as to establish a serial datacommunication channel therebetween.

As an example, referring now to FIG. 9, there is shown a secondembodiment of a system for transferring data, said system beingconstructed according to the teachings of the present invention andidentified generally by reference numeral 311.

System 311 is similar to system 11 in that system 311 comprises ananalyte test instrument (ATI) 313, a data management device (DMD) 315and an adaptor 317, wherein analyte test data stored in ATI 313 can bewirelessly transmitted to DMD 315 via adaptor 317.

The principal distinction between system 311 and system 11 lies in thefact that adaptor 317 releasably interconnects with ATI 313 in adifferent manner in which adaptor 17 releasably interconnects with ATI13. Specifically, as shown in FIG. 10, ATI 313 comprises a datacommunication device 327 which is in the form of a conventional,female-type, conductive phone jack receptacle and adaptor 317 comprisesa data communication device 361 which is in the form of conventional,male-type, conductive phone jack. Preferably, the phone jack receptacleof device 327 is sized and shaped to fittingly and releasably receivethe phone jack of device 361, with device 361 being disposed in directelectrical contact with device 327. As such, a serial data communicationpath can be established between adaptor 317 and ATI 313, which is highlydesirable.

It should be noted that the adaptors of the present invention which weredescribed in detail above can be used in conjunction with various typesof analyte test instruments. By providing adaptors which can be usedwith different types of analyte test instruments, the present inventionserves to create a standardized means for wirelessly transmitting dataof any format from any type of analyte test instrument to a common datamanagement device, which is highly desirable.

The embodiments shown in the present invention are intended to be merelyexemplary and those skilled in the art shall be able to make numerousvariations and modifications to it without departing from the spirit ofthe present invention. All such variations and modifications areintended to be within the scope of the present invention as defined inthe appended claims.

What is claimed is:
 1. A system, comprising: a monitor configured tostore analyte related data having a first data communication component,the first data communication component including an analyte test portconfigured for receiving an analyte test strip; a data management devicein data communication with the monitor over a second data communicationchannel; and a device configured for data communication with the monitorvia a first data communication channel, the device comprising a seconddata communication component wherein a portion of the second datacommunication component is configured to be removably received in theanalyte test port of the first data communication component to establishthe first data communication channel between the device and the monitor.2. The system of claim 1, wherein the device further comprises a powersource.
 3. The system of claim 1, wherein the analyte test stripincludes a blood glucose test strip.
 4. The system of claim 1, whereinthe second data communication component is adapted to be electrically ormechanically coupled to the first data communication component of themonitor.
 5. The system of claim 1, wherein the first data communicationcomponent includes at least one contact strip and is adapted toelectrically or mechanically receive at least the portion of the seconddata communication component.
 6. The system of claim 1, wherein one ormore of the first data communication channel or the second datacommunication channel is configured to support one or more of radiofrequency (RF) communication protocol, Bluetooth communication protocol,Zigbee communication protocol, or infrared communication protocol.
 7. Asystem, comprising: a monitor configured to store analyte related dataand having a first data communication component, the first datacommunication component including an analyte test port configured forreceiving an analyte test strip; a data management device in datacommunication with the monitor over a second data communication channel;and a device configured for data communication with the monitor via afirst data communication channel, wherein the device operatively coupledto the monitor to establish the first data communication channel betweenthe device and the monitor.
 8. The system of claim 7, wherein at least aportion of the device is configured to be removably received in theanalyte test port of the first data communication component to establishthe first data communication channel between the device and the monitor.9. The system of claim 7, wherein the analyte test strip includes ablood glucose test strip.
 10. The system of claim 7, wherein a seconddata communication component is adapted to be electrically ormechanically coupled to the first data communication component of themonitor.
 11. The system of claim 7, wherein the first data communicationcomponent includes at least one contact strip and is adapted toelectrically or mechanically receive at least a portion of a second datacommunication component.
 12. The system of claim 7, wherein one or moreof the first data communication channel or the second data communicationchannel is configured to support one or more of radio frequency (RF)communication protocol, Bluetooth communication protocol, Zigbeecommunication protocol, or infrared communication protocol.
 13. Amethod, comprising: providing a first data communication component to amonitor to configure the monitor to store analyte related data;providing an analyte test port to the first data communication componentto receive an analyte test strip; providing a data management device indata communication with the monitor over a second data communicationchannel; and configuring a device for data communication with themonitor via a first data communication channel, wherein configuring thedevice includes providing a second data communication component suchthat a portion of the second data communication component is configuredto be removably received in the analyte test port of the first datacommunication component to establish the first data communicationchannel between the device and the monitor.
 14. The method of claim 13,wherein the analyte test strip includes a blood glucose test strip. 15.The method of claim 13, electrically or mechanically coupling the seconddata communication component to the first data communication componentof the monitor.
 16. The method of claim 13, further including providingat least one contact strip to the first data communication component,wherein the one contract strip is adapted to electrically ormechanically receive at least the portion of the second datacommunication component.
 17. The method of claim 13, further includingconfiguring one or more of the first data communication channel or thesecond data communication channel to support one or more of radiofrequency (RF) communication protocol, Bluetooth communication protocol,Zigbee communication protocol, or infrared communication protocol.